FDA says look for options to Celebrex

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: FDA

"We?re leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," Acting FDA Commissioner Lester Crawford said Friday. "We do have great concern about this product (Celebrex) and the class of products."

"As a physician, you have to ask: Is the increased risk due to something common about all the drugs in that class or is it unique to that one medication? My personal opinion is that it is probably a class effect and that the whole class is probably suspect. And I don?t think this medication has that much more to offer than other traditional pain medications that are cheaper and probably safer," New Hampshire, state medical director, Dr. William Kassler, said.

"It?s on TV. It?s pushed by the pharmaceutical industry for everybody and clearly that is no longer the case. The FDA has tough decisions to make. Either take it off the market or determine it can be used appropriately for a small segment of the population for which it is clearly indicated," Kassler said.

"Both doctor and patient ought to be looking very carefully at this drug and weighing what we know are the potential risks against any potential benefits. . . . We?re going to have to pay attention to the science. We?re going to be hearing more about this in clinical and medical circles. This is just the beginning for this issue and it?s far from resolved," Kassler said.

"I think the trial concludes the controversy about whether there is a class effect of these drugs. Now there is clear evidence of it," said Dr. Garret A. FitzGerald, a cardiologist at the University of Pennsylvania. "You would need to believe the earth is flat if you thought this was just a coincidence."

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Michael Monheit, Esquire, Monheit Law, PC